Efficacy and Safety of Non-Invasive Low-Frequency Tibial Nerve Stimulator for Overactive Bladder
Study Overview
This study aimed to assess how effective and safe the non-invasive low-frequency tibial nerve stimulator (TNS-01) is compared to a sham treatment for patients with overactive bladder (OAB).
Participants
Patients diagnosed with primary OAB or showing at least one symptom of OAB participated in the study. Each participant attended three 30-minute sessions per week.
Methods
Participants were randomly assigned to either the TNS-01 group (active treatment) or the sham group (placebo). Both groups received treatments for 12 weeks. The main goal was to measure changes in the Overactive Bladder Symptom Score (OABSS) after 12 weeks.
Results
Out of 109 OAB patients, those in the TNS-01 group showed a significant improvement in OABSS compared to the sham group (2.83 vs 1.62). Additionally, the TNS-01 group experienced fewer daily urinary incontinence episodes (0.11 vs 0.68). Only one patient in the sham group reported a mild side effect (hematuria).
Conclusions
The TNS-01 device is both effective and safe for relieving OAB symptoms after 12 weeks of use.
Trial Registration
Clinical trial number: NCT04999657
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